Vitamin Lawyer Update Memo: June 6, 2008
This issue:
1. US and Japan Forming Health Food Alliance
2. Weight Control Dietary Supplements Under Attack
3. Professional Practice Record Keeping SOP Available
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Blog Update: NY to Mandate Forced Vaccine Pharma Profits
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1. US and Japan forming health food alliance
06-Jun-2008 (by Neil Merrett – “Two leading US nutrition groups are teaming up with a Japanese counterpart to combine their knowledge in a bid to meet both the domestic and international challenges facing the industry. … The Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the National Nutritional Foods Association of Japan (NNFA-J) yesterday agreed to work together to better deal with regulatory and research issues… ‘Emerging research is increasingly supporting the safety and benefits of supplements for maintaining good health and reducing the risk of chronic diseases," he stated. "Regulatory approaches in both countries should likewise reflect good science to help consumers make healthy decisions.’”
www. nutraingredients-usa. com/news/ng.asp?n=85762&c=gbrnO2ewSG3bTjEYx%2BWZAA%3D%3D
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2. Weight Control Dietary Supplements Under Attack
Dietary Supplements that support normal weight have been under increasing attack by both government and special interests. Even well-known weight loss brands such as TrimSpa® are failing (its parent company recently filed for bankruptcy).
Recently it seems that GlaxoSmithKline (GSK) will stop at nothing to rub out the competition when it comes to weight loss supplements. (No matter what your opinion is on weight loss supplements, this issue affects the vitamin industry as a whole.) GSK has petitioned FDA to classify all over-the-counter weight loss supplements as unapproved “drugs.” This means that mere overweight would be classified as a “disease” (as “obesity” is currently classified).
Furthermore, GSK hopes to remove any weight loss claims from dietary supplements. It should be noted that there is currently only one over-the-counter weight loss product with FDA approval: GSK’s alli®.
If FDA starts reclassifying normal conditions of life as “diseases” to protect the Pharmaceutical Industry, we may well see more dietary supplements threatened.
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3. Professional Practice SOPs
The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
Contains the following topics:
1. Maintaining copies of all paid invoices
2. Maintaining regular back-up copies of client database.
3. Maintaining copies product ordered for resale records
4. Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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